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FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings

The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.

Quality Control Compliance Quality

Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer

Having secured Medicare reimbursement, Seattle, Washington-based Indi Diagnostics, Inc. is getting ready to bring its liquid biopsy molecular test to pulmonologists in the US starting Q1 2018. The company said it will be first to introduce a liquid biopsy molecular diagnostic test in the country designed to help pulmonologists identify lung nodules that have a high probability of being benign, saving patients unnecessary invasive procedures.

Cancer In Vitro Diagnostics StartUps and SMEs

US Approvals Analysis: Cook Churns Out 510(k)s In Q3

The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

Approvals Innovation Research & Development

Device Week, Oct. 12, 2017 – Tomorrow's Technologies At The Medtech Conference; M&A Keeps A-Pace

In this edition of Device Week, find out which were the most interesting startups showcased at AdvaMed’s annual Medtech Conference, held at the end of September. Additionally, the last week has seen a surge in acquisition activity – which were the more notable deals that were cut?

Device Week M & A StartUps and SMEs
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Policy & Regulation Explore this Topic

Set Alert for Policy

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Advisory Committees Clinical Trials Regulation

Medtech Fees To Soar In Canada Under Government Proposals

The licence evaluation fee Health Canada charges for Class IV medical devices could jump from CAN$12,347-$22,560 to $30,063 under proposals by the government agency, which says the current fees it charges for medtech and pharma are outdated.

Approvals Canada Policy & Regulation

Big Promise For TransEnterix Robotic-Surgery Device, But Probably Won't Undermine Intuitive's Market

FDA's recent clearance of TransEnterix's Senhance System signals broad potential for robotically-assisted surgeries but the device is more likely to grow its own space than compete directly with Intuitive Surgical's daVinci products in many cases, analysts suggest.

Approvals Regulation

Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation

Regardless of the path that the UK-EU Brexit negotiations take, the UK MHRA and the bulk of the local medtech industry are very clear on one thing: The need to retain access to the nascent EU Medical Device and IVD Regulations – and with it, EU reciprocity on device regulation. Any alternative approach is likely to engender unfathomable difficulties and disadvantage for the homegrown UK medtech industry, stakeholders say.

United Kingdom Regulation

New Connected-Health Standards Signal US FDA's Future Thinking

Standards organizations say software and informatics standards recently recognized by US FDA are a sign of the technologies the agency expects to tackle in future product applications and a signal to industry about priorities.

Digital Health Standards

Canada Prepares To Publish Draft Rules On Release Of Clinical Data

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Clinical Trials Canada

UK IVD Industry Finds New Voice And Appetite For Challenges Ahead

The association of the IVD industry in the UK, BIVDA, is undergoing a rebrand and proactively positioning itself to reinforce the value proposition that diagnostics represent for stakeholders. A new whitepaper on the theme was one of the highlights of an upbeat 2017 annual general meeting, in which Brexit and the EU IVDR for once were not the "stars" of the show.

United Kingdom In Vitro Diagnostics

Three-Year EU MDR Transition Period? More Like 12-18 Months

So, you think you have nearly three years to comply with the EU's Medical Device Regulation and five years with the IVD Regulation. Not so. The clock has started ticking and industry has reason to be concerned.

Europe Medical Device

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover

CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.

Regulation FDA

Quality On The Brain: FDA Maturity Pilot Aims To Shift Industry's Compliance Mentality To A 'Quality Mindset'

An upcoming voluntary pilot program from US FDA will be the perfect vehicle to help drive a compliance-to-quality culture change at medical device firms, developers of the program say. To be stood up early next year, the pilot will see manufacturers use third-party assessors to measure the maturity of their quality systems and manufacturing processes. In a survey, early users of the Capability Maturity Model Integration (CMMI) appraisal process said it helped them identify ways to increase product quality.

Quality Control Compliance

Tossed Aside? Millennials More Likely To Ignore, Throw Out Product Recall Notices, Survey Finds

The survey of more than a thousand consumers shows that manufacturers might want to change the way they interact with people between the ages of 18 and 34 when communicating information about device recalls.

Recalls Quality Control

Commercial Explore this Topic

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Will AAA's Nuclear Med Offerings Turn M&A Buzz Into A Deal?

Advanced Accelerator Applications (AAA) has hit the headlines with recent rumors of a potential acquisition deal from Novartis. Now that the radiopharmaceutical company has its first therapeutic product approved and ready for commercialization, is AAA really ready to sign the dotted line?

Cancer Companies Commercial

Latest From Commercial

Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Advisory Committees Approvals

Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In IUD Sales

More religious-based college employers, and for-profit businesses with moral objections to contraceptive coverage, will be able to issue health plans denying intrauterine device and birth control coverage to their employees and students starting in 2018, under the administration's Oct. 6-issued "conscience rights" exemptions from Affordable Care Act (ACA) requirements. The interim final rules could dampen sales of IUDs and implants that have risen 5% in the last year at Bayer Healthcare and Allergan.

Gynecology & Urology Market Access

UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation

The UK National Institute for Health and Care Excellence is working on a new database of pre-launch-phase medtech products. The aim is to give NHS providers enough time to plan for the uptake of innovative technologies and, generally, to improve the pathway between development and adoption, says NICE medtech programs director Mirella Marlow.

United Kingdom Market Access

Philips' Profit To Be Dented By FDA-Decreed AED Sales Halt

On signing a consent decree with the US FDA, Philips is halting manufacture and sales of external defibrillators produced at two facilities until the agency is satisfied the company is complying with current good manufacturing practice requirements. The suspension is expected to impact Philips' EBITA for the fourth quarter 2017 and for 2018.

Cardiology Compliance

MDxHealth Gears Up For Major EU Growth

Cancer diagnostics company MDxHealth is poised for more commercial growth in 2018 following a move to larger lab facilities in Nijmegen, the Netherlands. The move is part of the company's strategy to grow commercialization of its SelectMDx prostate cancer test in Europe and conduct additional R&D activities.

Cancer In Vitro Diagnostics

Court Ruling May Help Life-Science Firms In IPR Patent Battles

En banc Federal Circuit says patent owners do not have to prove patentability of amended claims in inter partes review proceedings; judges issue five opinions in fractured decision.

Intellectual Property Legal Issues

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer

Having secured Medicare reimbursement, Seattle, Washington-based Indi Diagnostics, Inc. is getting ready to bring its liquid biopsy molecular test to pulmonologists in the US starting Q1 2018. The company said it will be first to introduce a liquid biopsy molecular diagnostic test in the country designed to help pulmonologists identify lung nodules that have a high probability of being benign, saving patients unnecessary invasive procedures.

Cancer In Vitro Diagnostics StartUps and SMEs

Latest From Research & Development

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.

Research & Development Personalized Medicine

OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India

Cardiovascular and diabetes device dominated September's list of medical device approvals from outside the US on Medtech Insight's Approvals Tracker. The 24 non-US approvals in September is below average for 2017, but one more than September of 2016 and keeps 2017 on a track to have about 40% more non-US approvals than 2016.

Approvals Innovation

OBD's Epigenetic Biomarker Tech Shows Ethnicity Issue-Free Dx Potential

Recent studies completed by epigenetic biomarker company Oxford BioDynamics have shown the company's platform technology EpiSwitch can diagnose and stage breast cancer and Amyotrophic Lateral Sclerosis (ALS). The Oxford spinout is the developer of a blood-based platform test for detecting chromosome confirmation signatures (CCSs), which overcome any ethinicity issues.

Clinical Trials Companies

Start-Up Spotlight: Arkis BioSciences, Endexo-Boosted Ventricular Drainage Catheter Reduces Obstructions

Arkis BioSciences Inc.'s newly launched CerebroFlo EVD catheter for treating intracranial hypertension offers an added benefit of being impregnated with Endexo, an antiocclusive agent that in laboratory studies has shown to dramatically reduce the incidence of thrombus formation, which can potentially reduce catheter obstructions.

StartUps and SMEs Start-up Spotlight

Augmenix Looks To Apply Hydrogel Technology Beyond Prostate Cancer

The company's SpaceOAR injected hydrogel spacer continues to prove effective at reducing the collateral damage from radiation treatment for prostate cancer. Now the Boston company hopes to apply the same bioabsorbable hydrogel technology to improve outcomes with radiation therapy for other cancers, including pancreatic and gynecological cancer.

Clinical Trials Innovation

Starts & Stops: Abbott, Medtronic Announce Major Trial Activities

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This edition includes entries from a variety of companies and technologies, including many post-market studies following regulatory approvals.

Starts & Stops Clinical Trials
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